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OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Breast Cancer
Mastectomy; Lymphedema

Treatments

Procedure: OPERA

Study type

Observational

Funder types

Other

Identifiers

NCT06415526
202400581B0

Details and patient eligibility

About

Current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. Breast reconstruction with free deep inferior epigastric artery perforator (DIEP) flap was considered the gold standard, however, the donor site morbidity remains an endless concern. Here we applied robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).

A retrospective chart review identified 14 patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction. The patient demographics and mastectomy and flap characteristics were reviewed.

Enrollment

14 patients

Sex

Female

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with ASA (American Society of Anesthesiologist) classification 1-2
  • Breast skin should be free from cancer involvement, with adequate tumor to skin distance, and the largest preoperative tumor size no more than 5 cm
  • The lesion should be located in any of the 4 quadrants away from the nipple, at least 1 cm distance between the lesion and the nipple

Exclusion criteria

  • Patients with previous pelvis surgeries (except C-section)

Trial design

14 participants in 1 patient group

OPERA group
Description:
Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction
Treatment:
Procedure: OPERA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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